Methylphenidate Hydrochloride

Product NDC
31722-927
11-digit product format
317220927
Labeler code
31722
Product ID
31722-927_3547512f-45f7-4c6a-8fb0-2144eff24b11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Camber Pharmaceuticals Inc.
Application
ANDA210354
Marketing category
ANDA
Marketing start
2018-03-01
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210354-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-29
A210354-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-29
A210354-003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A210354-001AB
A210354-002AB
A210354-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-2984e616aacf4f…
2026-09-14 22:38:342026-08A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-2984e616aacf4f…
2026-09-14 22:38:342026-08A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-2984e616aacf4f…
2026-08-18 06:07:402026-07A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210354-002METHYLPHENIDATE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORALAB2017-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210354-003METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALABRS2017-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210354-001METHYLPHENIDATE HYDROCHLORIDE2.5MGTABLET, CHEWABLE / ORALAB2017-12-29301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210354-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210354-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A210354-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A210354-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210354-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210354-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210354-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210354-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210354-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210354-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210354-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210354-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210354-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210354-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210354-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210354-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210354-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210354-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210354-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210354-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210354-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210354-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210354-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210354-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210354-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210354-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210354-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210354-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210354-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210354-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210354-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210354-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210354-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210354-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210354-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210354-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210354-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210354-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210354-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210354-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4B3SC438HIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091152Internal RxNorm lookup
1091322Internal RxNorm lookup
1091389Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-927-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET, CHEWABLE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-927-01EA - Each31722-927710a801a-3bc1-4417-a208-332d6130892012018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-927METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [CAMBER PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 1 package rows20231011_bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack7293dffd-eb01-43d4-b9c4-04f79bec180c2024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210354
application number: ANDA210354
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.91833146-fa95-471a-8b8d-6d36a2db5c9a2023-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210354
application number: ANDA210354
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e02023-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210354
application number: ANDA210354
ndc (product): 31722-927

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091322methylphenidate HCl 5 MG Chewable TabletPSN4de3567d-01e1-4be5-bfbc-0a4d6601a212103
1091322methylphenidate hydrochloride 5 MG Chewable TabletSCD4de3567d-01e1-4be5-bfbc-0a4d6601a212103
1091152methylphenidate HCl 10 MG Chewable TabletPSNbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091389methylphenidate HCl 2.5 MG Chewable TabletPSNbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091322methylphenidate HCl 5 MG Chewable TabletPSNbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091152methylphenidate hydrochloride 10 MG Chewable TabletSCDbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091389methylphenidate hydrochloride 2.5 MG Chewable TabletSCDbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091322methylphenidate hydrochloride 5 MG Chewable TabletSCDbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-927-0131722092701100 TABLET, CHEWABLE in 1 BOTTLE (31722-927-01) 2018-03-010000-00-00NoNoCurrent